MAUDE Adverse Event Report: LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 16, FIRM; MESH, SURGICAL

Catalog Number	1016002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240); Obstruction/Occlusion (2422); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/10/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Limited information was reported through a legal event that a patient was implanted with strattice firm on (b)(6) 2016.The form also indicates that on an unspecified date, the strattice implant had been ¿removed or revised¿.No information was provided on the indication for the initial surgery or the reason for the removal or revision.
Additional Manufacturer Narrative
The lot associated with this event was not reported and remains unknown; therefore a review into the device history records could not be performed.No strattice devices were returned for evaluation.Based on the limited information, and without relevant patient factors, a relationship between the event and the strattice could not be determined.Due to the legal process, if additional information is made available during legal proceedings, a supplemental report will be submitted.
Additional Manufacturer Narrative
A review of the device history record for strattice lot sp100392 has been completed.No deviations or non-conformances noted.This is a known potential adverse event addressed in the product labeling.Without relevant patient factors, a relationship between the strattice and this event could not be determined.Due to the legal process, if additional information is made available during legal proceedings, a supplemental report will be submitted.
Event or Problem Description
This is follow up#1 to report on 28/mar/2025, pmqa received notification from legal that the plaintiff profile form (ppf).As per the ppf form, the patient underwent recurrent incarcerated incisional hernia surgery and was implanted with the strattice device lot# sp100392-141 and ref.#(b)(4) on (b)(6) 2016.On (b)(6) 2018, patient underwent small-bowel resection, primary anastomosis, extensive lysis of adhesions, removal of prior mesh and repair of recurrent incarcerated incisional hernia with a non-abbive device, phasix mesh (lot #huby1146).The form lists the condition that was treated: (b)(6) 2016 - reduction and repair (strattice) of incisional hernia with small bowel repair and extensive lysis of adhesions.(b)(6) 2018 - abdominal pain, evaluation of sbo; ct ab/pel scan-small bowel obstruction secondary to ventral hernia containing both small and large bowel.(b)(6) 2018 - abdominal pain; small-bowel resection, primary anastomosis, extensive lysis of adhesions, removal of prior mesh and phasix mesh repair of recurrent incarcerated incisional hernia.On (b)(6) 2014, patient was implanted with a non-abbvie device, ventralight st, lot #huyb0394.On (b)(6) 2016, ventralight st mesh was revised and subsequently removed on 11/oct/2018.Between 2016-2019 - hernia repair and small bowel surgeries, post-ops.7/aug/2024 - abdominal pain; cramping.As reported in the initial: limited information was reported through a legal event that a patient was implanted with strattice firm on (b)(6) 2016.The form also indicates that on an unspecified date, the strattice implant had been ¿removed or revised¿.No information was provided on the indication for the initial surgery or the reason for the removal or revision.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 16, FIRM
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; one millennium way; branchburg NJ 08876
• Manufacturer (Section G): LIFECELL; one millennium way; branchburg NJ 08876
• Manufacturer Contact: terry ingram ; 1 millennium way; branchburg, NJ 08876 ; 8479366324
• MDR Report Key: 21345558
• Report Number: 1000306051-2025-00019
• Device Sequence Number: 7853758
• Product Code: FTM
• UDI-Device Identifier: 00818410010119
• UDI-Public: (01)00818410010119(10)SP100392(11)160517(17)180430
• Combination Product (Y/N): N
• PMA/510(K) Number: K070560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: 1016002
• Device Lot Number: SP100392
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2025
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female